Regulatory Open Forum

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  • 1.  Regulatory Affairs Conferences/Trainings?

    Posted 30-Nov-2022 15:44
    Hi all,

    Aside from RAPS Convergence and RAPS Euro Convergence, have any of you found any conferences or trainings/workshops that you have found particularly useful for someone in regulatory affairs in the pharmaceutical drug space?

    Thanks!

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    Marissa Berry, Ph.D., RAC
    Senior Manager, Regulatory Strategy
    Durham, NC
    United States
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  • 2.  RE: Regulatory Affairs Conferences/Trainings?

    Posted 02-Dec-2022 12:13
    I always enjoy the conferences put on by the FDA:
    https://www.fda.gov/drugs/news-events-human-drugs/regulatory-education-industry-redi-annual-conference-2022-06062022

    FDA Clinical Investigator Training Course (CITC) 2022 December 7 – 8, 2022
    https://sbiaevents.com/citc2022/#files

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    Karen Fan MSc RAC PEng PMP
    EU MDR Consultant
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    Original Message


  • 3.  RE: Regulatory Affairs Conferences/Trainings?

    Posted 03-Dec-2022 09:01
    Be sure to watch for the RAPS-AFDO Pharma Conference (formerly sponsored by Xavier Health). It heavily involves FDA. You won't be disappointed.

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    Edwin Bills MEd, BSc, RAC, ASQ Fellow, CQE, CQA, CMQ/OE
    Principal Consultant
    Overland Park KS
    United States
    elb@edwinbillsconsultant.com
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    Original Message


  • 4.  RE: Regulatory Affairs Conferences/Trainings?

    Posted 02-Dec-2022 14:40
    Hi Marissa, I would also also recommend taking a look at DIA (https://www.diaglobal.org) as well as TOPRA (https://www.topra.org/) in Europa. They have conferences on specific regulatory topics and DIA has a global conference with a regulatory track as well as many related tracks (PV, clinical trials, CMC...). Good luck!

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    Anna Sedello, PhD, RAC
    Director of Regulatory Affairs
    Palo Alto CA
    United States
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    Original Message


  • 5.  RE: Regulatory Affairs Conferences/Trainings?

    Posted 02-Dec-2022 15:23
    Hi Marissa, 

    I find DIA Global a fabulous conference to attend. It is in Boston next June.
    Patricia

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    Patricia Smith PhD, RAC
    Senior Director, Regulatory Affairs, Quality Assurance, Pharmacovigilance and Medical Information
    Saint-Laurent QC
    Canada
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    Original Message


  • 6.  RE: Regulatory Affairs Conferences/Trainings?

    Posted 02-Dec-2022 16:31
    Hi,
    I have always found the CDER SBIA workshops to be interesting.  If you are in the generics space, the Center for Complex Generics has some good webinars/conferences.  Also, I highly recommend the Generic Drug Forum held each spring, if your focus is on generics.

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    Lisa Apolis, RAC
    Apolis Regulatory Consulting
    Georgia, USA
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    Original Message


  • 7.  RE: Regulatory Affairs Conferences/Trainings?

    Posted 04-Dec-2022 23:38
    Duke offers a 6 week, online Regulatory Affairs Training Program that covers the following topics:
    • Drug Development and FDA Meetings
    • Applicability of FDA Drug Regulations to Clinical Studies
    • IND Content, Format, Review and Maintenance
    • Medical Device Development and FDA Meetings
    • Applicability of FDA Device Regulations to Clinical Studies
    • IDE Preparation, Submission, and Maintenance

    Here is the link: https://medschool.duke.edu/research/research-support/research-support-offices/office-regulatory-affairs-and-quality-3

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    Shilpa Pathak
    Powell OH
    United States
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    Original Message


  • 8.  RE: Regulatory Affairs Conferences/Trainings?

    Posted 05-Dec-2022 11:12
    Thank you all for the helpful suggestions!

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    Marissa Berry, Ph.D., RAC
    Senior Manager, Regulatory Strategy
    Durham, NC
    United States
    ------------------------------

    Original Message


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